Nannan Gao

About Nannan Gao

Regulatory Affairs professional experienced in integrated product development and regulatory compliance, with a solid understanding of regulatory requirements in the pharmaceutical and biotechnology sectors. Strong knowledge of FDA regulatory frameworks and proven experience in developing documents for submissions including INDs, NDAs, and BLAs. Demonstrated strength in cross-functional collaboration, with excellent written and verbal communication skills. Strong attention to detail and organizational skills, with the ability to work independently and manage multiple projects simultaneously.

Experience

1. Regulatory Scientist i

   Rho

   Oct 2024 — Present

   Leading cross-functional integration and strategic planning for global drug and biologic programs, contributing to regulatory filings, authority interactions, and program risk mitigation Leads the integration of clinical, nonclinical, chemistry, manufacturing, and regulatory components for pharmaceutical and biologic development projects. Supports planning and execution of meetings with regulatory authorities, actively contributing to discussions as needed. Develops internal SOPs for ex-US clinical trial application requirements and processes. Ensures alignment with strategic objectives by monitoring progress of key deliverables against global development plans and addressing risks proactively. Oversees scope, budgets, and timelines for external vendors, including consultants, medical writers, and nonclinical toxicology service providers, ensuring efficient project execution. Coordinates the authorship, biostatistical analysis, and data submission for regulatory filings, including INDs, NDAs, and BLAs, while ensuring compliance with electronic submission standards. Authors and performs quality reviews of complex regulatory documents such as Module 2 documents, Integrated Summaries of Safety and Efficacy (ISS and ISE), study protocols, Investigator\'s Brochures (IBs), Meeting Background Materials, and clinical study reports (CSRs).

Education

• Xinxiang Medical University

  Bachelor of Science - BS, Life Science and Biotechnology

  2006 — 2010

• University of Chinese Academy of Sciences

  Doctor of Philosophy - PhD, Cell Biology

  2010 — 2017